December 18, 2009
BOSTON (Reuters) - Celgene Corp said Friday that initial results from a clinical trial showed multiple myeloma patients who took its drug Revlimid following a stem cell transplant had a 58 percent reduction in risk of their disease progressing.
The company's shares rose nearly 10 percent to $55.60 in afternoon trading on Nasdaq.
"We anticipated Revlimid would likely be effective in this setting, but these results come sooner than expected and indicate robust Revlimid benefits," said Brian Abrahams, an analyst at Oppenheimer & Co. "We believe this news provides important momentum for Celgene entering 2010."
Revlimid is already approved in combination with dexamethasone to treat patients with multiple myeloma who have received at least one prior treatment.
The latest study was led by the Cancer and Leukemia Group B (CALGB). The group's independent data and safety monitoring board reported the trial had met its main goal of showing a statistically significant improvement in time to disease progression.
As a result, the trial was stopped early.
The study was sponsored by the National Institutes of Health under a clinical trials agreement with Celgene.
The data are important because they add weight to the theory that giving patients Revlimid as a maintenance therapy, either after first receiving other drugs or after receiving a stem cell transplant, could improve outcomes.
Earlier this month, Celgene reported data that showed patients who took Revlimid plus the standard drugs melphalan and prednisone, and followed by Revlimid alone, did better in delaying disease progression than those who took melphalan and prednisone alone.
"This is now a second piece of powerful evidence that Revlimid confers substantial benefit when used as maintenance therapy in multiple myeloma patients," said Geoffrey Porges, an analyst at Sanford Bernstein."
If Revlimid can be shown to add benefit as a maintenance therapy and is approved as a first line treatment, it could increase sales from an expected $1.7 billion this year to $3.6 billion by 2013, according to the consensus forecast from Thomson Pharma.
Autologous blood stem cell transplantation is a procedure in which a patient's own blood stem cells are removed, the patient is then treated with high doses of chemotherapy or radiation or both to kill the cancer and then the blood stem cells are put back into the patient.
A total of 568 patients with multiple myeloma who had received no more than 12 months of prior therapy and no prior transplant were enrolled in the trial. The patients all received a transplant followed by melphalan. After the transplant, patients took either Revlimid or a placebo until their disease progressed.
Among those who received the placebo, half saw their cancer worsen within 778 days, or 25.9 months. By comparison, the median time to progression in the Revlimid group could not be defined because fewer than half the patients had a worsening of their disease at that time.
This represents a 58 percent reduction in the risk of disease progression in the Revlimid group.
Revlimid is a derivative of thalidomide, sold by Celgene as Thalomid. (Reporting by Toni Clarke; editing by Dave Zimmerman and Andre Grenon)
(Contributed by T. Miller, CMR)
Friday, 18 December 2009
Thursday, 17 December 2009
Landmark Islet Cell Transplantation Was A Collaborative Effort
December 15, 2009
Posted: 05:49 PM ET
By Val Willingham
CNN Medical Producer
On November 21, Senior Airman Tre Porfirio was struck in the gut by three high velocity bullets while serving in Afghanistan. Porfirio, from St. Mary's, Georgia, was seriously injured; his entire digestive system was in danger of shutting down. During two operations in combat hospitals, surgeons removed his gallbladder along with portions of his large and small intestines, part of his stomach and a large section of his pancreas.
Porfirio was flown back to the United States immediately after emergency surgery, and taken to Walter Reed Army Medical Center, outside of Washington, D.C.
Col. Craig Shriver, chief of general surgery at Walter Reed, knew he had to remove the airman's remaining pancreas, which was found to be damaged beyond repair. "The optimal procedure at this point was to remove his entire remaining pancreas to prevent further leakage of the pancreatic enzymes and control the bleeding, which could be fatal," said Shriver. "We knew that the procedure would lead to the most severe and life-threatening form of diabetes, which tends to be very brittle and difficult to control in this type of situation.”
In an effort to save Porfirio from severe diabetes, Shriver turned to other surgeons for suggestions. Dr. Rahul Jindal, a transplant surgeon also at Walter Reed, had training and experience in islet cell transplantation, which is considered the best hope for curing diabetes. In islet cell transplantation, the insulin-producing islets are taken from a donor pancreas, treated and then put in the patient's liver where they begin to produce insulin for the body, even if there is no pancreas. In this case, the islet cells would come from Porfirio's own pancreas.
"Isolation and purification of pancreatic islets is a very intricate procedure, which requires a specialized laboratory, and there are only a few such facilities in the United States," said Jindal.
But Jindal knew of the perfect facility for the job; he turned for help to the Diabetes Research Institute at the University of Miami Miller School of Medicine. The director of the institute, Dr. Camillio Ricordi, developed the method for isolating the islet cells from the pancreas and was considered a pioneer in the field. Ricordi immediately agreed to help, noting that he would do "anything to help a wounded warrior."
Doctors at Walter Reed then proceeded to remove the remaining portion of Porfirio’s pancreas, packed it in ice and sent it to Miami.
On Thanksgiving Day, just five days after Porfirio's initial injury, the cell processing team at the Diabetes Research Institute spent six hours performing the islet cell isolation and purification procedure. "More than 220,000 purified islets were then suspended in a specialized cold solution and flown back to Walter Reed,” said Ricordi.
That afternoon, on that very same Thanksgiving Day, the islet cells were injected into Porfirio’s liver with Ricordi and his team coordinating the procedure with surgeons at Walter Reed via an Internet connection, a sort of high-tech telemedicine event.
In the three weeks since being wounded in Afghanistan, Porfirio has undergone 11 surgeries and, according to doctors, is "doing well." In a press conference held Tuesday at Walter Reed Medical Center, surgeons noted that there was evidence of the airman’s islet cells functioning in his liver less than one week after surgery; 15 days after the procedure, the transplanted islet cells were functioning in the normal range. His physicians say as time goes on, the islet cells in the liver will get stronger; when that happens, Porfirio's insulin requirement is expected to decrease. And although he'll still have a form of diabetes, the complication won't be as dangerous and he'll have a better quality of life.
Doctors from both the University of Miami Miller School of Medicine and surgeons at Walter Reed believe this transplantation is the first of its kind in a wounded soldier. They hope the success of the procedure will allow for more cases of islet cell transplantation in military personnel, as more of our fighting men and women return from war with injuries like those of Senior Airman Porfirio.
Posted by: Val Willingham - CNN Medical Producer
Filed under: Health • diabetes (contributed by T. Miller, CMR)
Posted: 05:49 PM ET
By Val Willingham
CNN Medical Producer
On November 21, Senior Airman Tre Porfirio was struck in the gut by three high velocity bullets while serving in Afghanistan. Porfirio, from St. Mary's, Georgia, was seriously injured; his entire digestive system was in danger of shutting down. During two operations in combat hospitals, surgeons removed his gallbladder along with portions of his large and small intestines, part of his stomach and a large section of his pancreas.
Porfirio was flown back to the United States immediately after emergency surgery, and taken to Walter Reed Army Medical Center, outside of Washington, D.C.
Col. Craig Shriver, chief of general surgery at Walter Reed, knew he had to remove the airman's remaining pancreas, which was found to be damaged beyond repair. "The optimal procedure at this point was to remove his entire remaining pancreas to prevent further leakage of the pancreatic enzymes and control the bleeding, which could be fatal," said Shriver. "We knew that the procedure would lead to the most severe and life-threatening form of diabetes, which tends to be very brittle and difficult to control in this type of situation.”
In an effort to save Porfirio from severe diabetes, Shriver turned to other surgeons for suggestions. Dr. Rahul Jindal, a transplant surgeon also at Walter Reed, had training and experience in islet cell transplantation, which is considered the best hope for curing diabetes. In islet cell transplantation, the insulin-producing islets are taken from a donor pancreas, treated and then put in the patient's liver where they begin to produce insulin for the body, even if there is no pancreas. In this case, the islet cells would come from Porfirio's own pancreas.
"Isolation and purification of pancreatic islets is a very intricate procedure, which requires a specialized laboratory, and there are only a few such facilities in the United States," said Jindal.
But Jindal knew of the perfect facility for the job; he turned for help to the Diabetes Research Institute at the University of Miami Miller School of Medicine. The director of the institute, Dr. Camillio Ricordi, developed the method for isolating the islet cells from the pancreas and was considered a pioneer in the field. Ricordi immediately agreed to help, noting that he would do "anything to help a wounded warrior."
Doctors at Walter Reed then proceeded to remove the remaining portion of Porfirio’s pancreas, packed it in ice and sent it to Miami.
On Thanksgiving Day, just five days after Porfirio's initial injury, the cell processing team at the Diabetes Research Institute spent six hours performing the islet cell isolation and purification procedure. "More than 220,000 purified islets were then suspended in a specialized cold solution and flown back to Walter Reed,” said Ricordi.
That afternoon, on that very same Thanksgiving Day, the islet cells were injected into Porfirio’s liver with Ricordi and his team coordinating the procedure with surgeons at Walter Reed via an Internet connection, a sort of high-tech telemedicine event.
In the three weeks since being wounded in Afghanistan, Porfirio has undergone 11 surgeries and, according to doctors, is "doing well." In a press conference held Tuesday at Walter Reed Medical Center, surgeons noted that there was evidence of the airman’s islet cells functioning in his liver less than one week after surgery; 15 days after the procedure, the transplanted islet cells were functioning in the normal range. His physicians say as time goes on, the islet cells in the liver will get stronger; when that happens, Porfirio's insulin requirement is expected to decrease. And although he'll still have a form of diabetes, the complication won't be as dangerous and he'll have a better quality of life.
Doctors from both the University of Miami Miller School of Medicine and surgeons at Walter Reed believe this transplantation is the first of its kind in a wounded soldier. They hope the success of the procedure will allow for more cases of islet cell transplantation in military personnel, as more of our fighting men and women return from war with injuries like those of Senior Airman Porfirio.
Posted by: Val Willingham - CNN Medical Producer
Filed under: Health • diabetes (contributed by T. Miller, CMR)
Sunday, 13 December 2009
New Cancer Therapy Shown to Extend Lives
Spotlight - Breast Cancer
Some women with advanced breast cancer may have a new treatment option. A combination of two drugs that more precisely targets tumors significantly extended the lives of women who had stopped responding to other medicines, doctors reported Friday (11_Dec., 2009). Herceptin and Tykerb aim at a protein, HER-2, that is made in abnormally large quantities in about one-fourth of all breast cancers. Herceptin blocks the protein on the cell's surface; Tykerb does it inside the cell. Patients with advanced breast cancer who took Herceptin with another drug, Tykerb, lived about five months longer than women who took only Tykerb.
(from Chicago Tribune/Marilynn Marchione-Associated Press) 12_Dec.,2009
Some women with advanced breast cancer may have a new treatment option. A combination of two drugs that more precisely targets tumors significantly extended the lives of women who had stopped responding to other medicines, doctors reported Friday (11_Dec., 2009). Herceptin and Tykerb aim at a protein, HER-2, that is made in abnormally large quantities in about one-fourth of all breast cancers. Herceptin blocks the protein on the cell's surface; Tykerb does it inside the cell. Patients with advanced breast cancer who took Herceptin with another drug, Tykerb, lived about five months longer than women who took only Tykerb.
(from Chicago Tribune/Marilynn Marchione-Associated Press) 12_Dec.,2009
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